BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VENTRICULAR BOLT ICP MONITORING KIT

    MDR report key: 5414370 · Received February 5, 2016

    Report

    Report Number
    2023988-2016-00003
    Event Type
    Malfunction
    Date Received
    February 5, 2016
    Report Date
    January 20, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K914735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SECOND OF 3 REPORTS (SAME PRODUCT ID, SIMILAR PROBLEM, DIFFERENT INCIDENTS). DOCTOR STATED THAT WHEN INSERTING THE 1104HM CAMINO CATHETER INTO THE BOLT, THE CATHETER STICKS WHEN IT GOES THROUGH THE WHITE PLASTIC PORTION OF THE BOLT. ONCE IT WAS INSERTED, HE WENT TO PULL BACK ON IT AND LOCK IT AND IT BECAME STUCK. HE STATED THE SITUATION HAS OCCURRED WITH THE 1104HM CATHETERS 10 TIMES. NO SPECIFIC PATIENT OR INCIDENT DETAILS FOR EACH OCCURRENCE WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. LINKED TO MFG. REPORT NUMBERS: 2023988-2016-00002 AND 2023988-2016-00004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72405 MICRO VENTRICULAR BOLT ICP MONITORING KIT N/A GWM INTEGRA NEUROSCIENCES CA/USA

    Patients

    Seq Age Sex Outcome Treatment
    1